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Online, Guided Interventions to Reduce Generalized Anxiety Disorder Among Indian University Students

Primary Purpose

Anxiety Disorders

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Lantern: Guided self-help program

Mental Health Online: Self-help program

About this trial

This is an interventional treatment trial for Anxiety Disorders focused on measuring guided self-help, student mental health, task shifting, prevention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Current student of one of the 3 college sites
Subjects must have a clinical or subclinical diagnosis of Generalized Anxiety Disorder (GAD); clinical diagnosis is met by self-reporting DSM-IV criteria for GAD; subclinical diagnosis is met by scoring a 5.7 or above using diagnostic scoring of the GAD-Q-IV

Exclusion Criteria:

Unable to give informed consent.
Is currently receiving mental health treatment.
Has clinical PTSD (a score of 38 or above on the PCL5)

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Arm Label

Lantern: Guided self-help program

Mental Health Online: Self-help program

Delayed Program

Arm Description

Subject assigned to the Lantern intervention will receive 3-month access to a web-based, CBT-based guided self-help intervention for GAD. In the program, they receive psycho-education about GAD and the management of symptoms of GAD along with access to an "e-coach" who can monitor their progress in the program and provide feedback and encouragement via messaging and one voice call.

Subject assigned to the Mental Health Online (MHO) intervention will receive 3-month access to a web-based, CBT-based self-help intervention for GAD. In the program, they receive psycho-education about GAD and the management of symptoms of GAD.

Subject assigned to this arm will receive one of the online programs in 9 months.

Outcomes

Primary Outcome Measures

Change in GAD symptoms measured by the 4th edition of the Generalized Anxiety Disorder Questionnaire (GAD-Q-IV)

Compare GAD symptoms using the 4th edition of the Generalized Anxiety Disorder Questionnaire (GAD-Q-IV) between subjects randomized to guided self-help online programs versus self-help online programs versus waitlist control, when used for the treatment of anxiety among Indian university students with clinical and subclinical GAD.

Secondary Outcome Measures

Sustained change in GAD symptoms measured by the 4th edition of the Generalized Anxiety Disorder Questionnaire (GAD-Q-IV)

Change in panic disorder symptoms measured by The Panic Disorder Self-Report (PDSR)

Compare panic disorder symptoms using the The Panic Disorder Self-Report (PDSR) between subjects randomized to guided self-help online programs versus self-help online programs versus waitlist control, when used for the treatment of anxiety among Indian university students with clinical and subclinical GAD.

Change in social phobia symptoms measured by the Social Phobia Diagnostic Questionnaire (SPDQ)

Compare social anxiety disorder symptoms using the Social Phobia Diagnostic Questionnaire (SPDQ) between subjects randomized to guided self-help online programs versus self-help online programs versus waitlist control, when used for the treatment of anxiety among Indian university students with clinical and subclinical GAD.

Change in post-traumatic stress disorder symptoms measured by the Post Traumatic Stress Disorder Checklist for DSM-5 (PCL5)

Compare post traumatic stress disorder (PTSD) symptoms using the Post Traumatic Stress Disorder Checklist for DSM-5 between subjects randomized to guided self-help online programs versus self-help online programs versus waitlist control, when used for the treatment of anxiety among Indian university students with clinical and subclinical GAD.

Change in obsessive compulsive disorder (OCD) symptoms measured by the LEVEL 2-Repetitive Thoughts and Behaviors-Adult (adapted from the Florida Obsessive-Compulsive Inventory [FOCI] Severity Scale [Part B])

Compare OCD symptoms using the the LEVEL 2-Repetitive Thoughts and Behaviors-Adult (adapted from the Florida Obsessive-Compulsive Inventory [FOCI] Severity Scale [Part B]) measure between subjects randomized to guided self-help online programs versus self-help online programs versus waitlist control, when used for the treatment of anxiety among Indian university students with clinical and subclinical GAD.

Change in specific phobia symptoms measured by questions of distress severity for specific fears

Compare specific phobia symptoms using questions of distress severity for specific fears (dogs, snakes, spiders/bugs/insects, heights, flying, small enclosed spaces, driving, traveling in cars/trains/buses, bridges, tunnels, water, blood, other) between subjects randomized to guided self-help online programs versus self-help online programs versus waitlist control, when used for the treatment of anxiety among Indian university students with clinical and subclinical GAD.

Change in depression symptoms measured by the Depression Anxiety Stress Scales (DASS)

Compare depression symptoms using the Depression Anxiety Stress Scales (DASS) between subjects randomized to guided self-help online programs versus self-help online programs versus waitlist control, when used for the treatment of anxiety among Indian university students with clinical and subclinical GAD.

Change in worry symptoms measured by the Penn State Worry Questionnaire (PSWQ)

Compare worry symptoms using the Penn State Worry Questionnaire (PSWQ) between subjects randomized to guided self-help online programs versus self-help online programs versus waitlist control, when used for the treatment of anxiety among Indian university students with clinical and subclinical GAD.

Change in insomnia symptoms measured by the Insomnia Severity Index (ISI)

Compare insomnia symptoms using the Insomnia Severity Index between subjects randomized to guided self-help online programs versus self-help online programs versus waitlist control, when used for the treatment of anxiety among Indian university students with clinical and subclinical GAD.

Change in subject self-efficacy measured by the General Self-efficacy Scale

Compare subject self-efficacy using the General Self-efficacy Scale between subjects randomized to guided self-help online programs versus self-help online programs versus waitlist control, when used for the treatment of anxiety among Indian university students with clinical and subclinical GAD.

Change in emotional distress from anxiety measured by the Patient Reported Outcomes Measurement Information System (PROMIS) Emotional Distress from Anxiety measure

Compare subject emotional distress from anxiety using the Patient Reported Outcomes Measurement Information System (PROMIS) Emotional Distress from Anxiety measure between subjects randomized to guided self-help online programs versus self-help online programs versus waitlist control, when used for the treatment of anxiety among Indian university students with clinical and subclinical GAD.

Change in self-report difficulties with emotions, concentration, and relationships measured by the Strengths and Difficulties Questionnaire (SDQ)

Compare subject perception of difficulties with emotions, concentration, and relationships using the Strengths and Difficulties Questionnaire between subjects randomized to guided self-help online programs versus self-help online programs versus waitlist control, when used for the treatment of anxiety among Indian university students with clinical and subclinical GAD.

Change in relationship satisfaction measured by the PROMIS Satisfaction with Social Roles and Activities measure

Compare subject satisfaction with social roles using the PROMIS Satisfaction with Social Roles and Activities measure between subjects randomized to guided self-help online programs versus self-help online programs versus waitlist control, when used for the treatment of anxiety among Indian university students with clinical and subclinical GAD.

Factors associated with poor program engagement and/or discontinuation measured by analysis of self-report assessments of motivation, belief in program efficacy, satisfaction, etc. as well as analysis of demographics, comorbid mental illness, etc.

Determine factors associated with poor program engagement and/or discontinuation in study participants in the guided and self-help intervention arms. Factors associated with poor program engagement and/or discontinuation will include demographics, belief in program efficacy, motivation, comorbid mental illness, socioeconomic status, and English language competence.

Change in non-specific distress measured by the Kessler Distress Measure (K10)

Compare subject perception of non-specific distress using the Kessler Distress measure (K10) between subjects randomized to guided self-help online programs versus self-help online programs versus waitlist control, when used for the treatment of anxiety among Indian university students with clinical and subclinical GAD.

Full Information

NCT ID

NCT02410265

First Posted

March 30, 2015

Last Updated

March 16, 2020

Sponsor

Stanford University

Collaborators

National Institute of Mental Health and Neuro Sciences, India

1. Study Identification

Unique Protocol Identification Number

NCT02410265

Brief Title

Online, Guided Interventions to Reduce Generalized Anxiety Disorder Among Indian University Students

Official Title

Using Technology to Address Anxiety and Stress in Indian University Students

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Completed

Study Start Date

January 2015 (undefined)

Primary Completion Date

December 2016 (Actual)

Study Completion Date

December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Stanford University

Collaborators

National Institute of Mental Health and Neuro Sciences, India

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This controlled, three-arm, randomized (1:1:1), multi-site trial will evaluate the efficacy, feasibility and acceptability of cognitive-behavioral therapy (CBT)-based online guided and unguided self-help intervention to reduce Generalized Anxiety Disorder (GAD) in Indian university students. The investigators aim to assess if these novel electronic health (eHealth) interventions can be integrated into Indian university systems to increase access to efficacious, less stigmatized, and cost-effective mental healthcare.

Detailed Description

Students from three Indian colleges will be invited to complete an online, self-report survey. Based on their answers, they are categorized into clinical, subclinical, and asymptomatic for Generalized Anxiety Disorder (GAD). Those who meet the diagnostic criteria for GAD as detailed in the Diagnostic and Statistical Manual of Mental Disorders (DSM), 4th Edition are classified as clinical. Those who score a 5.7 or above using dimensional scoring of the GAD-Q-IV but are not "clinical" are classified as subclinical. All others are asymptomatic. After ruling out those with a clinical PTSD diagnosis (scoring 38 or above on the PCL5) and those currently receiving mental healthcare treatment, those who are clinical and subclinical are offered the opportunity to use one of the online programs. Those who accept are randomized between a guided self-help program, a self-help program, and a waitlist control group. Each student who enrolls will be reassessed at post-intervention (3 months) and followup (6 months later, or 9 months after completing baseline). Additionally, those who are classified as asymptomatic are invited to complete additional followup surveys at 3 and 9 months to provide data on anxiety symptom change over time.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anxiety Disorders

Keywords

guided self-help, student mental health, task shifting, prevention

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

193 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lantern: Guided self-help program

Arm Type

Experimental

Arm Description

Arm Title

Mental Health Online: Self-help program

Arm Type

Experimental

Arm Description

Arm Title

Delayed Program

Arm Type

No Intervention

Arm Description

Subject assigned to this arm will receive one of the online programs in 9 months.

Intervention Type

Behavioral

Intervention Name(s)

Lantern: Guided self-help program

Intervention Description

Intervention Type

Behavioral

Intervention Name(s)

Mental Health Online: Self-help program

Intervention Description

Primary Outcome Measure Information:

Title

Change in GAD symptoms measured by the 4th edition of the Generalized Anxiety Disorder Questionnaire (GAD-Q-IV)

Description

Time Frame

Baseline to 3-month post-intervention

Secondary Outcome Measure Information:

Title

Sustained change in GAD symptoms measured by the 4th edition of the Generalized Anxiety Disorder Questionnaire (GAD-Q-IV)

Description

Time Frame

Baseline to 3-month post-intervention, and 6-month follow-up

Title

Change in panic disorder symptoms measured by The Panic Disorder Self-Report (PDSR)

Description

Time Frame

Baseline to 3-month post-intervention, and 6-month follow-up

Title

Change in social phobia symptoms measured by the Social Phobia Diagnostic Questionnaire (SPDQ)

Description

Time Frame

Baseline to 3-month post-intervention, and 6-month follow-up

Title

Change in post-traumatic stress disorder symptoms measured by the Post Traumatic Stress Disorder Checklist for DSM-5 (PCL5)

Description

Time Frame

Baseline to 3-month post-intervention, and 6-month follow-up

Title

Description

Time Frame

Baseline to 3-month post-intervention, and 6-month follow-up

Title

Change in specific phobia symptoms measured by questions of distress severity for specific fears

Description

Time Frame

Baseline to 3-month post-intervention, and 6-month follow-up

Title

Change in depression symptoms measured by the Depression Anxiety Stress Scales (DASS)

Description

Time Frame

Baseline to 3-month post-intervention, and 6-month follow-up

Title

Change in worry symptoms measured by the Penn State Worry Questionnaire (PSWQ)

Description

Time Frame

Baseline to 3-month post-intervention, and 6-month follow-up

Title

Change in insomnia symptoms measured by the Insomnia Severity Index (ISI)

Description

Time Frame

Baseline to 3-month post-intervention, and 6-month follow-up

Title

Change in subject self-efficacy measured by the General Self-efficacy Scale

Description

Time Frame

Baseline to 3-month post-intervention, and 6-month follow-up

Title

Change in emotional distress from anxiety measured by the Patient Reported Outcomes Measurement Information System (PROMIS) Emotional Distress from Anxiety measure

Description

Time Frame

Baseline to 3-month post-intervention, and 6-month follow-up

Title

Change in self-report difficulties with emotions, concentration, and relationships measured by the Strengths and Difficulties Questionnaire (SDQ)

Description

Time Frame

Baseline to 3-month post-intervention, and 6-month follow-up

Title

Change in relationship satisfaction measured by the PROMIS Satisfaction with Social Roles and Activities measure

Description

Time Frame

Baseline to 3-month post-intervention, and 6-month follow-up

Title

Description

Time Frame

Baseline to 3-month post-intervention

Title

Change in non-specific distress measured by the Kessler Distress Measure (K10)

Description

Time Frame

Baseline to 3-month post-intervention, and 6-month follow-up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Current student of one of the 3 college sites Subjects must have a clinical or subclinical diagnosis of Generalized Anxiety Disorder (GAD); clinical diagnosis is met by self-reporting DSM-IV criteria for GAD; subclinical diagnosis is met by scoring a 5.7 or above using diagnostic scoring of the GAD-Q-IV Exclusion Criteria: Unable to give informed consent. Is currently receiving mental health treatment. Has clinical PTSD (a score of 38 or above on the PCL5)

12. IPD Sharing Statement

Citations:

PubMed Identifier

34881930

Citation

Newman MG, Kanuri N, Rackoff GN, Jacobson NC, Bell MJ, Taylor CB. A randomized controlled feasibility trial of internet-delivered guided self-help for generalized anxiety disorder (GAD) among university students in India. Psychotherapy (Chic). 2021 Dec;58(4):591-601. doi: 10.1037/pst0000383.

Results Reference

derived

PubMed Identifier

26679295

Citation

Kanuri N, Newman MG, Ruzek JI, Kuhn E, Manjula M, Jones M, Thomas N, Abbott JA, Sharma S, Taylor CB. The Feasibility, Acceptability, and Efficacy of Delivering Internet-Based Self-Help and Guided Self-Help Interventions for Generalized Anxiety Disorder to Indian University Students: Design of a Randomized Controlled Trial. JMIR Res Protoc. 2015 Dec 11;4(4):e136. doi: 10.2196/resprot.4783.

Results Reference

derived

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Online, Guided Interventions to Reduce Generalized Anxiety Disorder Among Indian University Students

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